The Effects of Prune Juice on Bowel Movement Patterns, Constipation Symptoms, and Quality of Life

Dalin Tzu Chi General Hospital

Status: Not yet enrolling

Conditions: Functional Constipation in Elderly; Constipation in Older Adults

Treatments: Dietary Supplement: High-Dose Prune Juice; Dietary Supplement: Low-Dose Prune Juice; Dietary Supplement: Medium-Dose Prune Juice

Study type: Interventional

Funder types: Other

Identifiers

NCT06963125

B11304037

Details and patient eligibility

About

This study investigates the effects of different prune juice dosages on bowel movement patterns, constipation symptoms, and quality of life in older adults. Using a factorial experimental design, 90 participants aged 65 to 100 with functional constipation will be randomly assigned to receive 100 mL, 150 mL, or 200 mL of prune juice daily for four weeks. The study aims to determine a safe and effective dosage for constipation management, offering a non-pharmacological approach to improving bowel health in older adults.

Full description

Constipation is a prevalent issue among older adults, leading to physical discomfort and long-term health complications. Non-pharmacological interventions are essential for effective management. This study aims to compare the effects of different prune juice dosages on bowel movement patterns, constipation symptoms, and quality of life to determine a safe and effective dosage for older adults. A factorial experimental design will be employed, with 90 participants aged 65 to 100 who are conscious, able to express their opinions, and diagnosed with functional constipation. Participants will be randomly assigned to three groups receiving 100 mL, 150 mL, or 200 mL of prune juice daily for four weeks. The outcomes will be assessed at five time points: before the intervention (T0), after one week (T1), after two weeks (T2), after three weeks (T3), and after four weeks (T4).

Enrollment: 90 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Older adults aged 65 to 100 years
• Cognitively aware and able to express their opinions
• Diagnosed with functional constipation

Exclusion criteria

• Diagnosis of diabetes mellitus
• Cognitive impairment, including moderate to severe dementia or psychiatric disorders
• Aphasia
• Severe hearing impairment
• Presence of gastrointestinal diseases, including:
• Gastrointestinal bleeding
• Intestinal obstruction
• Abdominal tumors
• Irritable bowel syndrome
• Acute diverticulitis
• Diarrhea
• Crohn's disease
• Ulcerative colitis
• History of abdominal surgery
• Regular use of probiotics
• Regular use of traditional Chinese medicine or folk remedies for constipation relief
• Difficulty swallowing or risk of aspiration
• Major illnesses, such as current cancer treatment or severe cardiovascular diseases
• Currently hospitalized

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Experimental Group 1

Experimental group

Description:

30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.

Treatment:

Dietary Supplement: Low-Dose Prune Juice

Experimental Group 2

Experimental group

Description:

30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.

Treatment:

Dietary Supplement: Medium-Dose Prune Juice

Experimental Group 3

Experimental group

Description:

30 elderly individuals residing in long-term care facilities, aged between 65 and 100 years, who have been diagnosed with functional constipation.

Treatment:

Dietary Supplement: High-Dose Prune Juice